KATEGORIE: QUALITY SYSTEMS

QMSR (Quality Management System Regulation)

Die aktualisierte FDA-Verordnung (gültig ab 2026), die die QSR durch Einbeziehung von ISO 13485:2016 ersetzt.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

FDA’s Quality Management System Regulation (QMSR) modernizes device quality system requirements, aligning more closely with ISO 13485 while retaining FDA inspection authority.

PROCESS / STEPS

Gap-assess current QSR procedures vs QMSR/ISO 13485 expectations.
Update SOPs, training, and internal audits.
Prepare inspection readiness under the new framework.
Monitor FDA transition timelines and enforcement communications.

EXAMPLES

Manufacturers already certified to ISO 13485 still need FDA-specific processes (e.g., certain reporting interfaces).

RELATED GUIDES & TOOLS

SOURCES

FDA QMSR final rule info ↗

Track regulatory signals related to QMSR (Quality Management System Regulation) across 27 authorities in real time.

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